ABSTRACT

There is a strong argument that usability tests of medical devices, particularly summative usability tests, should cover every task a user might perform with a given device. If you are wondering about the logic of this argument, place yourself in the passenger seat of a recently certified airliner. Would you be comfortable if the manufacturer tested only a fraction of the components of the airplane or if usability testing of the cockpit instrumentation included only a subset of tasks? Undoubtedly, your answer is no. Now, picture yourself on the operating table and ask yourself if you would be comfortable if the manufacturers of the surrounding equipment limited their testing. Again, your answer is undoubtedly no.